Is the On-Site Evaluation Report sufficient to demonstrate GMP compliance of the foreign drug establishment?
A.2 No. An On-Site Evaluation (OSE) is a product-specific evaluation of the manufacture of a drug conducted on-site by a Qualified Authority to assess the conformity with the drug submission. An OSE does not cover all the sections of GMP requirements and when submitted alone is not considered sufficient to demonstrate GMP compliance of the foreign drug establishment. For further information, please consult the Health Products and Food Branch Inspectorate policy document “Guidance on Evidence to Demonstrate Drug Compliance of Foreign Sites (GUI-0080)”.
Related Questions
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